Kornimate/medical-research-clean huggingface dataset:
phase ii feasibility study of dendritic cell vaccination for newly diagnosed glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. chemotherapy will be administered after three vaccinations for one year or until progression of disease.

two to six weeks after surgery, patients with newly diagnosed glioblastoma multiforme (gbm) will undergo a six-week course of radiotherapy with concurrent chemotherapy (temozolomide). between three and seven weeks after completing radiotherapy/chemotherapy, patients will undergo leukapheresis to collect white blood cells. these cells will be grown into dendritic cells, and cultured with tumor cells from the individual patient. vaccinations will be given every two weeks for a total of three vaccinations. four weeks after the third vaccination patients will resume chemotherapy for one year or until disease progression.

Eligibility criteria:
inclusion criteria: * histologically proven gbm with central pathology review at dartmouth-hitchcock medical center (dhmc) * tumor specimen obtained at the time of surgery adequate for vaccination * 18 years of age or older * karnofsky performance status 60% or greater * absolute neutrophil count (anc) greater than or equal to 1.5 x 10 9th/l * platelets greater than or equal to 100 x 10 9th/l * aspartate aminotransferase (ast) or alanine aminotransferase (alt) less than or equal to 5 times the upper limits of normal (uln) * total bilirubin less than or equal to 1.5 times uln * serum creatinine less than or equal to 1.5 times uln, or estimated creatinine clearance greater than or equal to 60 ml/min * no known immunosuppression other than chemo-related * negative hiv serologies * no evidence of acute or chronic hepatitis on standard hepatitis c and b screening tests * no chemotherapy within four weeks prior to leukapheresis * radiotherapy at outside institution is permitted if tissue was obtained at time of surgery at dhmc and patient is willing to follow-up per protocol * off steroids for at least two weeks before leukapheresis * no second malignancies except non-melanoma skin cancer, and non-invasive cancer such at cervical cis, superficial bladder cancer or breast cis * negative serum or urine pregnancy test for women of childbearing potential * no serious uncontrolled medical disorder or active infection * all patients must give informed consent * no history of clinical evidence of active autoimmune disease exclusion criteria: * invasive cancers in the past 5 years * rheumatologic/autoimmune disease * pregnancy or unwillingness to remain on acceptable form of birth control during study * major cardiac, pulmonary, or other systemic disease; viral hepatitis; hiv infection

Keywords: immunotherapy cancer vaccine glioblastoma multiforme
psychosocial factors and cardiovascular disease

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to evaluate the role of psychosocial factors in the development of hypertension and cardiovascular disease. to estimate the prevalence of masked hypertension and its potential role in the development of subclinical cardiovascular disease to compare the reliability of office blood pressure (bp), home bp and ambulatory bp, and their associations with subclinical cardiovascular disease

design narrative: the studies had several interrelated themes. one was to explore the relationships between environmental stress and blood pressure over a range of time courses, with acute laboratory studies at one extreme, and long- term prospective studies at the other. the basic model of stress included three elements: the objective nature of the stressor, the individual's perception of it, and his or her physiological susceptibility. this model incorporated elements of the karasek job strain model and the frankenhaueser effort-distress model, with two components corresponding to demand and control. a third dimension was social support. these models were tested under both laboratory and field conditions. blood pressure was the main dependent variable, together with structural changes in the heart and carotid arteries. five projects were included. project l evaluated the ability of ambulatory blood pressure, and blood pressure variability, to predict cardiovascular morbidity, and also included a cross-sectional study comparing the relationships between blood pressure and target organ damage in black and white individuals. the hypothesis that white coat hypertension is a condition associated with lower risk than sustained hypertension was also tested. project 2 (the work site blood pressure study) prospectively evaluated the effects of job strain and social support on blood pressure and other outcome variables in a working population. project 3 studied psychosocial and hormonal factors influencing diurnal variations of blood pressure in women, including the changes associated with menstruation and the menopause. project 4 (the masked hypertension study) assessed the prevalence of masked hypertension (normal bp in the clinic setting, but elevated bp in one's usual environment) and its association with subclinical cardiovascular disease (cvd); \~50% of the sample was re-evaluated an average of 6 years later. project 5 (improving the detection of hypertension) had repeat assessments of clinic bp, home bp and ambulatory bp in order to evaluate the test-retest reliability of each, and compare their associations with subclinical cvd. the study was renewed in fy 1998, fy 2003 and in fy 2009 to continue follow-up and analysis.

Eligibility criteria:
employed screening blood pressure \<=160/105 mmhg not taking antihypertensive medication no evidence of secondary hypertension no history of cardiovascular disease (myocardial infarction, stroke, heart failure, peripheral vascular disease).

Keywords: ambulatory blood pressure monitoring masked hypertension
comparison of volinanserin and lormetazepam in the treatment of insomnia characterized by sleep maintenance difficulties

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the primary objective is to compare the potential for next-day residual effects of volinanserin 2 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties. secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.


Eligibility criteria:
inclusion criteria: * out-patients with primary insomnia according to diagnostic and statistical manual of mental disorders (dsm-iv-tr) criteria exclusion criteria: * based on patient's information, the patient has spent less than 6.5 hours or more than 9.0 hours, in bed, each night, over the preceding two weeks * based on patient's information, the patient complains of less than one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month * disturbances of sleep maintenance parameters based on the patient's sleep questionnaire during the run-in period differing from pre-defined criteria. * pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control * night shift workers and individuals who nap 3 or more times per week * consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: insomnia sleep maintenance
factors associated with coronary heart disease in african americans in the jackson heart study

Conditions: Cardiovascular Diseases; Coronary Disease

Summary: coronary heart disease (chd) is the leading cause of deaths that are related to cardiovascular disease in the united states, and mississippi's chd mortality rate is the highest in the nation. this study will examine data from the jackson heart study to determine the effect of socioeconomic status and psychosocial factors on chd risk in african americans in mississippi.

chd is a disease that is characterized by narrowing of the coronary arteries that supply blood to the heart. as a result, insufficient amounts of oxygen and nutrients reach the heart, which can cause chest pain or heart attack. studies have shown that people's socioeconomic status is associated with their health, and that african americans experience the highest rates of heart disease in the u.s. the jackson heart study (jhs) is currently being conducted in jackson, mississippi, and is studying the factors that influence the development of cardiovascular disease in african american men and women. this study will examine data from the jhs to determine the effect of socioeconomic status and psychosocial factors on chd risk in african americans in mississippi. this study will recruit participants from the jhs only. participants will report to the study site at least once for 4.5 hours for baseline measurements. visits will include measurements of body size and blood pressure, an electrocardiogram, an echocardiogram, an ultrasound of the carotid artery, blood and urine collection, a lung function test, and interviews regarding health status and sociocultural aspects of life. follow-up evaluations will occur 5 and 10 years after starting the study. outcomes will include self-report and electrocardiogram-defined chd, as well as measures of various social and psychological factors.

Eligibility criteria:
inclusion criteria: * participant in the jackson heart study * diagnosis of coronary heart disease exclusion criteria: * n/a

Keywords: racial disparities psychosocial risk factors neighborhood socioeconomic status cvd chd
management of hepatitis c in hiv infected injection drug users (idus)

Conditions: HIV Infection; Hepatitis C

Summary: the principal goal of this research project is to evaluate the natural history of hcv and liver disease and its treatment in hiv-infected persons who use drugs. research procedures will focus on determining liver disease prevalence and severity within this population. this is an observational study without study specific interventions.

the principal goal of this research project is to evaluate the natural history of hcv and liver disease and its treatment in hiv-infected persons who use drugs. the recent availability of a novel, non-invasive method of measuring hcv disease stage makes it possible to test the relationship of hcv disease stage and the management of coinfected idus with adequate precision. the investigators will apply the innovative technology, elastography (fibroscan®) to ask whether the marked differences in the final disease outcome, end-stage liver disease (esld), can be explained by a measure of liver stiffness as assessed by elastography (fibroscan®). while advances in non-invasive disease assessment are critical to hcv management, the greatest challenge to improving hcv treatment effectiveness in coinfected persons remains low rates of treatment uptake and adherence, even when freely accessible. in response to this glaring disparity, the investigators will test potent behavioral reinforcement interventions to improve the management of hcv disease by adapting a rigorously studied contingent behavioral incentives program to the treatment to coinfected idus. hepatitis c treatment eligibility: to determine the population prevalence of significant liver disease in coinfected idus using an innovative, non-invasive methodology (transient elastography, fibroscan®) to measure liver stiffness. liver disease staging: to test the hypothesis that liver stiffness, assessed by a novel, non-invasive methodology, is predictive of the development of esld, defined as hepatic decompensation, hepatocellular cancer, and liver-related death, in coinfected idus.

Eligibility criteria:
inclusion criteria: * current or prior drug use * reactive hcv antibody * reactive hiv antibody exclusion criteria: * women may not undergo fibroscan while pregnant * persons with implanted cardiac devices may not undergo fibroscan

Keywords: hiv human immunodeficiency virus acquired immune deficiency syndrome virus aids virus immunodeficiency virus, human virus, human immunodeficiency hepatitis c hepatitis c, chronic hepatitis c virus hepatitis c antibodies hepatitis c antigens
low density lipoprotein cholesterol (cldl) as a cardiovascular disease risk factor in rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Cardiovascular Disease

Summary: the investigators hypothesize that cldl levels are elevated in ra patients and represents an important mechanism for accelerated atherosclerosis leading to excess cardiovascular disease (cvd) in rheumatoid arthritis (ra) patients. the purpose of this study is to improve understanding of the reasons for increased cardiovascular diseases (such as heart attack and stroke) seen in patients with rheumatoid arthritis (ra, an arthritis that causes inflammation and destruction of joints). specifically, the study plans to determine whether a particular type of change in proteins in ldl cholesterol ("bad cholesterol") known as carbamylation is an important risk factor for cardiovascular diseases in ra patients. the study will utilize a case-control study design. a total of 120 subjects (males and females between the ages of 18 and 80) may be enrolled in order to ensure that 100 subjects (50 ra case subjects and 50 age and sex matched controls) complete the study. procedures will consist of a single visit for each subject during which a screening evaluation, an enrollment evaluation, and a single blood draw will be performed.


Eligibility criteria:
inclusion criteria: for cases: * fulfill the american college of rheumatology (acr) 1987 classification criteria for ra * have currently active disease as assessed by clinical disease activity index (cdai)score (a validated composite ra activity index) of \> 10 * have ≥ 3 swollen joints for controls: * control subjects will be age, sex, and 5-year age categories matched to cases * no historical diagnosis of ra and other primary autoimmune or inflammatory disorders exclusion criteria: for both cases and controls: renal failure (estimated gfr \< 60 ml/min) documented within 3 months of study enrollment (from either subject's self-report or review of available medical records) * known clinical history of cvd * current cancer (other than skin) * current or recent (within past 2 weeks) infection * individuals taking lipid-lowering medications * any other condition the pi staff feels will jeopardize the health and welfare of the participants * rheumatoid vasculitis (for cases only)

Keywords: rheumatoid arthritis cldl cardiovascular disease
reading and stuttering

Conditions: Dyslexia

Summary: dyslexia is a common neurodevelopmental condition, which manifests itself in the form of reading difficulties and occurs in 7-10% of the population (peterson \& pennington, 2012). as for dyslexia, it is one of the most common learning disorders and the most common cause of difficulties with reading, writing, and spelling. the global prevalence of dyslexia is estimated to be between 5% and 10% of the population, but it may be as high as 17% (sprenger-charolles et al., 2011). stuttering is a speech disorder characterized by involuntary, audible, or silent repetitions or prolongations of sounds or syllables, along with disturbances in the fluency of verbal phrases.stuttering and dyslexia are two processing deficits that have an impact on a person's social and academic lives, especially as they usually affect the pediatric population more than adults. even though they affect different domains, they have similar characteristics in their pathogenesis, epidemiology, and impact on life (algaidy et al., 2023). the aim of the study will be to identify the prevelance of dyslexia in developmental stuttering.


Eligibility criteria:
inclusion criteria: * children with stuttering exclusion criteria: * children with delayed language development
efficacy and safety study of ingavirin® 90 mg once daily to treat influenza and other acute viral infections in adults

Conditions: Common Cold; Influenza, Human; Acute Respiratory Infection

Summary: the purpose of this study is to determine whether ingavirin® 90 mg once daily is effective and safe for the treatment of influenza and other laboratory confirmed acute respiratory viral infections in the course of standard therapy in patients 18-60 years old.

randomized, multicenter, double-blind, parallel-group, placebo-controlled trial of the efficacy and safety of ingavirin in the treatment of influenza and other acute viral respiratory infection. study treatment was 5 days followed by 2 ± 1 days of follow up period. thus, study participation was 7 ± 1 days (8 days max).

Eligibility criteria:
inclusion criteria: * patients with clinically diagnosed influenza, body temperature ≥ 38 ºс or other acute respiratory viral infection, body temperature ≥ 37 ºс, with no less than 2 symptoms of catarrhal and intoxication each: * intoxication symptoms: dizziness, headache, chills, fever, sweating, fatigue, myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances, decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs. * catarrhal symptoms: sore throat, rhinorrhea and nasal congestion, difficulty swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough, expectoration. * laboratory confirmation of viral origin of the disease * uncomplicated influenza and other acute respiratory viral infections * interval between onset of symptoms and enrollment to the study not more than 48 hours * have read, understood and signed an informed consent form exclusion criteria: * complicated course of influenza and other acute respiratory viral infections (secondary bacterial infection) * pregnancy and breastfeeding * severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis) * cancer, hiv infection, tuberculosis, including those in history * history of alcohol and drug abuse

Keywords: respiratory tract infections acute respiratory viral infection
interest of nitazoxanide treatment of enterocytozoon bieneusi intestinal microsporidiosis

Conditions: Microsporidiosis Intestinal

Summary: microsporidia are pathogenic fungi mainly responsible for profuse watery diarrhea, requiring management in immunocompromised patients. the main immunocompromised population affected by these infections consists of solid organ transplant recipients (sot), mainly kidney (\~70% of cases in immunocompromised patients). in this population, the infection is severe, and becomes chronic in the absence of appropriate care, the species enterocytozoon bieneusi being found in more than 95% of these cases. reducing immunosuppression (adjustment of immunosuppressive therapy) can sometimes be enough to eliminate the pathogen. however, in some cases, specific treatment is necessary. the only molecule whose efficacy has been proven to date to treat infections caused by e. bieneusi is fumagillin (flisint®), however its production has been stopped for almost 2 years. due to the therapeutic impasse, the use of nitazoxanide (alinia®) to treat e. bieneusi microsporidiosis is becoming common, despite the lack of proof of its efficacy. it seems important and urgent to evaluate the relevance of the use of nitazoxanide, particularly in sot, for the treatment of intestinal microsporidiosis due to e. bieneusi.


Eligibility criteria:
inclusion criteria: * with a diagnosis of intestinal infection caused by e. bieneusi between 01/01/2018 and 03/31/2022 * having received treatment with nitazoxanide ("nitazo" group), or fumagillin ("fuma" group), or albendazole ("abz") or having received no specific treatment but having benefited from an adjustment of the doses of immunosuppressants ("is" group) exclusion criteria: * with a diagnosis of extraintestinal infection * with a diagnosis of infection by a species other than e. bieneusi

Keywords: microsporidia enterocytozoon bieneusi solid organ transplant
artificial intelligence for determination of gastroscopy surveillance intervals

Conditions: Helicobacter Pylori Infection; Atrophic Gastritis; Intestinal Metaplasia; Low Grade Intraepithelial Neoplasia; High Grade Intraepithelial Neoplasia; Early Gastric Cancer; Gastric Cancer

Summary: the purpose of this study is to develop and validate a clinical decision support system based on automated algorithms. this system can use natural language processing to extract data from patients' endoscopic reports and pathological reports, identify patients' disease types and grades, and generate guidelines based follow-up or treatment recommendations


Eligibility criteria:
inclusion criteria: * patients aged 18 - 80 years * patients underwent endoscopic examination exclusion criteria: * patients with the contraindications to endoscopic examination * patients with imcomplete examination information * patients undergo endoscopy for therapy * patients have history of upper gastrointestinal surgery * patients with duodenal or laryngeal neoplasms * patients with gastrointestinal submucosal tumor
randomized trial of immediate endoscopic necrosectomy vs. step-up endoscopic interventions in necrotizing pancreatitis

Conditions: Pancreatitis,Acute Necrotizing

Summary: this is a randomized trial comparing immediate endoscopic necrosectomy vs. step-up endoscopic interventions in patients with necrotizing pancreatitis.

in patients with necrotizing pancreatitis, there has been a recent shift away from surgical debridement (surgical necrosectomy) towards minimally invasive endoscopic treatment. endoscopic management involves the creation of a fistula (tract) between the gastric or duodenal wall and the necrotic collection, under the guidance of endoscopic ultrasound (eus) with subsequent placement of a stent. in addition, performing endoscopic necrosectomy, which involves extraction of necrotic material under direct endoscopic visualization has increased rates of treatment success to greater than 80%. however to date, there are currently scant data on the optimal timing of endoscopic necrosectomy. the aim of this randomized trial is therefore to compare the clinical outcomes between patients undergoing immediate endoscopic necrosectomy compared to step-up endoscopic interventions in patients undergoing endoscopic therapy for necrotizing pancreatitis.

Eligibility criteria:
inclusion criteria: 1. age 18 years or over 2. symptomatic necrotic collection (that is suspected or confirmed to be infected), diagnosed on mri or ct abdomen/pelvis (seen as a fluid collection in the setting of documented pancreatic necrosis that contains necrotic material and encased within a partial or complete wall) 3. necrotic collection of any size with extent to necrosis of ≥ 33% and any number of loculations, located within the pancreatic/peri-pancreatic space 4. necrotic collection visualized on eus and amenable to eus-guided drainage exclusion criteria: 1. age \< 18 years 2. females who are pregnant 3. necrotic collection that is not amenable for eus-guided drainage 4. irreversible coagulopathy (defined as inr \>1.5, thrombocytopenia with platelet count \< 50,000/ml) 5. use of anticoagulants that cannot be discontinued for the procedure 6. unable to obtain consent for the procedure from either the patient or lar